An open label, multicentre, randomised, 2-cohort, sequential and crossover study to assess the relative oral bioavailability of MT-7117 higher content tablets versus MT-7117 lower content tablets and the pharmacokinetics of MT-7117 under various gastric conditions (fed and fasted, and following administration of a proton pump inhibitor and an acidic beverage) in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
Investigational Centre(s)
Germany, Germany
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose and up to 48 hours following each single dose
Area under the plasma concentration time curve from time zero to last quantifiable concentration (AUC0-t)
Time frame: Pre-dose and up to 48 hours following each single dose
Area under the plasma concentration time curve from time zero to infinity (AUC0-inf)
Time frame: Pre-dose and up to 48 hours following each single dose
Incidence of adverse events (AEs) and serious AEs
Time frame: up to 48 hours post dose
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